Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 January 2015

12 January 2015

PRAC considers risk of severe allergic reactions with ambroxol- and bromhexine-containing medicines to be small

The Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of medicines containing ambroxol or bromhexine, and has concluded that the risk of severe allergic reactions is small, but that the product information should be updated.

The PRAC recommended adding a new warning, together with advice to discontinue treatment immediately if symptoms of allergy or severe skin reactions occur.

More information is provided in the table below.

Agenda

Agenda - PRAC draft agenda of meeting 6-9 January 2015

Recommendation by PRAC

Ambroxol and bromhexine hydrochloride-containing medicines
Article-31 referral: Ambroxol and bromhexine hydrochloride-containing medicines Ambroxol and bromhexine Article-31 referral - PRAC considers risk of severe allergic reactions with ambroxol- and bromhexine-containing medicines to be small